Much like the experience we have all recently gained in the United States during the deployment of UDI for Class 3 and now Class 2 devices and soon Class 1. The goals of the European Medical Device Regulation (MDR) and In-Vitro Diagnostic Directive (IVDR) are to provide for the safety and well-being of the consumers that the products serve.
Challenges to be compliant:
- Pragmatyxs has determined that medical device manufacturers are often working with labeling systems that are out dated and are not prepared to provide the robust and dynamic platform required to meet the new compliance standards.
- Some organizations have developed custom solutions that have served them to date, but do not have the flexibility to meet the new and evolving compliance standards.
- Organizations that have de-centralized purchasing or have grown through acquisition have multiple manufacturers systems in place that are operating independently, creating issues in the proper flow in their distribution supply chain operations.
Complying with the European MDR and IVDR legislation is a complex issue for most medical device manufacturers. Investing in new software and systems to meet these requirements is just the beginning. A second consideration is selecting the correct partner to deploy, integrate, develop and maintain these systems. This is a critical decision.
At Pragmatyxs we have determined that this comprehensive approach provides the ability to:
- Produce compliant labels now and in the future for MDR and IVDR and the next generation of compliance requirements that meet or exceed the standards.
- Provide benefits beyond compliance by increasing traceability, providing accuracy in your supply chain operations and producing quality control benefits
We welcome the opportunity to share our experience with you.